IBUPROFEN- ibuprofen capsule, liquid filled

United States - English - NLM (National Library of Medicine)

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Active ingredient:
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Available from:
Publix Super Markets Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/Fever reducer
Authorization status:
Abbreviated New Drug Application
Authorization number:
56062-131-06, 56062-131-27, 56062-131-58

IBUPROFEN- ibuprofen capsule, liquid filled

Publix Super Markets Inc

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Publix Super Markets, Inc. Ibuprofen Liquid Gels Drug Facts

Active ingredient (in each capsule)

Solubilized Ibuprofen equal to 200 mg Ibuprofen (NSAID)*

(present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

Purpos e

Pain reliever/Fever reducer

Us es

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach

bleeding. The chance is higher if you

temporarily relieves minor aches and pains due to:

headache

toothache

backache

menstrual cramps

the common cold

muscular aches

minor pain of arthritis

temporarily reduces fever

hives

facial swelling

asthma (wheezing)

shock

skin reddening

rash

blisters

are age 60 or older

have had stomach ulcers or bleeding problems

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart

failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer

than directed.

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

take a blood thinning (anticoagulant) or steroid drug

take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen,

or others]

have 3 or more alcoholic drinks every day while using this product

take more or for a longer time than directed

if you have ever had an allergic reaction to any other pain reliever/fever reducer

right before or after heart surgery

stomach bleeding warning applies to you

you have problems or serious side effects from taking pain relievers or fever reducers

you have a history of stomach problems, such as heartburn

you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a

stroke

you are taking a diuretic

under a doctor’s care for any serious condition

taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

taking any other drug

take with food or milk if stomach upset occurs

you experience any of the following signs of stomach bleeding:

feel faint

vomit blood

have bloody or black stools

have stomach pain that does not get better

you have symptoms of heart problems or stroke:

chest pain

trouble breathing

weakness in one part or side of body

slurred speech

leg swelling

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen during the last 3

months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in

the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Other information

Inactive ingredients

ammonium hydroxide, caprylic and capric acid triglycerides, FD&C green No. 3, gelatin, isopropyl

alcohol, lecithin, macrogol/PEG 400, polyethylene glycol, polyvinyl acetate phthalate, potassium

hydroxide, propylene glycol, purified water, SDA 35A alcohol, sorbitol sorbitan solution, titanium

dioxide

Principal Display Panel

ibuprofen liquid gels**

SOLUBILIZED IBUPROFEN CAPSULES, 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

ACTUAL SIZE

80 LIQUID GELS**

**LIQUID-FILLED CAPSULES

Compare to Advil® Liqui-Gels® active ingredient

redness or swelling is present in the painful area

any new symptoms appear

do not take more than directed

the smallest effective dose should be used

adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist

if pain or fever does not respond to 1 capsule, 2 capsules may be used

do not exceed 6 capsules in 24 hours, unless directed by a doctor

children under 12 years: ask a doctor

each capsule contains: potassium 20 mg

read all warnings and directions before use. Keep carton.

store at 68-77 F (20-25 C)

avoid excessive heat above 104 F (40 C)

IBUPROFEN

ibuprofen capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:56 0 6 2-131

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

IBUPRO FEN (UNII: WK2XYI10 QM) (IBUPROFEN - UNII:WK2XYI10 QM)

IBUPROFEN

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

AMMO NIA (UNII: 5138 Q19 F1X)

FD&C GREEN NO . 3 (UNII: 3P3ONR6 O1S)

GELATIN (UNII: 2G8 6 QN327L)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO LYVINYL ACETATE PHTHALATE (UNII: 58 QVG8 5GW3)

PO TASSIUM HYDRO XIDE (UNII: WZH3C48 M4T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SO RBITAN (UNII: 6 O9 2ICV9 RU)

Product Characteristics

Color

GREEN (Light Green)

S core

no sco re

S hap e

OVAL

S iz e

19 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:56 0 6 2-131-58

1 in 1 CARTON

0 8 /0 2/20 17

1

40 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:56 0 6 2-131-27

1 in 1 CARTON

0 8 /0 7/20 17

2

8 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:56 0 6 2-131-0 6

1 in 1 CARTON

0 1/17/20 18

3

16 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 359 9

0 8 /0 2/20 17

Labeler -

Publix Super Markets Inc (006922009)

Publix Super Markets Inc

Revised: 3/2019

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